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Maker of Zohydro Sues Massachusetts to Block Ban

Zogenix filed the lawsuit in U.S. District Court on April 7.

A screenshot from DrugFree.org about Zohydro ER. Credit: DrugFree.org
A screenshot from DrugFree.org about Zohydro ER. Credit: DrugFree.org

The maker of a new opioid-based painkiller that health officials worry will lead to more addiction issues has gone to court suing to overturn a ban in Massachusetts, according to The Associated Press.

Zogenix, the maker of Zohyrdro, filed the suit in U.S. District Court requesting the court overturn an executive order by Gov. Deval Patrick, D-MA, banning prescriptions of the drug.

The company, which is based in California, noted that the Food and Drug Administration approved the drug last year. Zohydro is the only extended release capsule form of hydrocodone bitartrate available on the market and is recommended for use to those who need “alternative treatment options” that “are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” according to the drug makers’ website.

According to reports, the drug was approved without tamper resistant safeguards and is more potent that other forms of the drug, which worries public health officials. The worries, and the ever increasing heroin, Oxycodone, and other substance abuse addiction issues, described as a public health emergency by some, have led to legislation to ban the drug in Kentucky, West Virginia, and Vermont. Similar legislation will also be filed soon in New Hampshire. 

Last month, U.S. Rep. Stephen Lynch, D-MA, has also co-sponsored legislation to rescind the FDA approval, while 28 states requested the FDA last year to “reassess” its approval the drug, according to DrugFree.org.

Read the full report from The Associated Press here.

Curious April 10, 2014 at 03:08 AM
Malcom your formulate so that is cannot be crushed into a injectable or inhalable form. Usually by making it in a wax matrix so when the tablet is crushed or the capsule open its not in a injectable or inhalable form. Oxycontin has done this when they became the hot street prescription drug. Will someone figure how to bypass the tamper resistant methodology, most likely but that will take time and make it that much more expensive and not readily available. The problem with zohydro is you simple empty the capsule and crush up the contents and you have hydrocodone at 10x the potency of what's currently available, That just makes it more attractive to the dealers and user and will lead to more overdoses and more deaths, The company will promote it as pure hydrocodone and safer because it has no acetaminophen and physicians will jump for it forgetting its greater abuse potential. This is one case where the FDA should have listened to their advisory panel and not approved the drug in the form it was proposed. MA is only one of some six or more states trying to block it use and several members of congress have requested the FDA to retract it approval.
John Doe April 10, 2014 at 10:39 AM
Curious, your position is preposterous. We should not approve drugs that help 90% of patients that try them, because 10% could POSSIBLY get addicted to them? That is ludicrous and irresponsible.
Vincent DiRico April 10, 2014 at 11:41 AM
I'll admit "tamper resistant safeguards" (aren't just the bottles they come in) are a pleasant surprise to me, thanks for that info. ---> 10% abuse seems like a very high number but I agree the people who need this help should not be kept from getting it.
Julia Simmons April 11, 2014 at 08:58 PM
Here is an email I sent to my Attorney General when I found out he had joined in on the hysteria: I was very upset today when I heard that my State's Attorney General was joining the fight against the FDA's approval of Zohydro Er. I have been living with the pain of severe Rheumatoid Arthritis since I was 15. Despite my enthusiasm for school and good grades, I was in too much pain to achieve the goals I wanted for myself. Then in 2008, I found a compassionate doctor who was willing to prescribe opiates and everything changed. I have been able to work two jobs, enjoy my old hobbies, buy a beautiful home, and I plan to continue my education this fall...There is just one problem. My doctors recently discovered that my liver was enlarged from RA involvement and I will not be able to continue taking the daily doses of acetaminophen that are forced on me in the name of abuse prevention. Unfortunately this is an all too common dilemma, as many of the conditions that cause chronic pain also cause liver damage. Without a Hydrocodone only alternative, like Zohydro, I will soon have to stop the treatment that has given me my life back. If you succeed in your efforts, you will be forcing me back into a life of pain. I may loose my job, my house, and all the progress I have made. Why should I be made to suffer to protect those who would choose to abuse opiates? I did not CHOOSE my misfortune. Is the wellbeing of the drug abuser inherently more valuable than mine? I appreciate you taking the time to hear my arguments. I beg you to please reconsider your stance on this issue and to put your faith in the doctors and regulators of the FDA. Please help your constituents to understand the needs of the patients. Surely you can agree that the rights of the law abiding citizen out weight concerns for the criminal, no matter what the consequences. Fiat justitia ruat caelum
AHM April 12, 2014 at 07:09 AM
On your side Julia. I am in 24/7 pain also. I take as little pain medication as possible. I see these problem as being in the doctors hands solely. They have to use wise judgment on handing these out based on a persons needs and condition. Too many are just handing them out freely. Many of us patients are responsible too and should not be made to suffer from the abuse of a few doctors handing them out like candy. And it is not up to the state government to know what is best for us. Enough of this nanny government crap.

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